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NCT Number: NCT07091630

A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP

The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo for 24 weeks (6 months). Following part A, participants will enter part B in which all participants will receive empasiprubart for 96 weeks (24 months).

More information can be found here: https://clinicaltrials.argenx.com/emnergize

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Key information

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy Autoimmune Diseases Autoimmune Diseases of the Nervous System CIDP Chronic Disease Chronic Inflammatory Demyelinating Polyradiculoneuropathy Demyelinating Diseases Disease Attributes Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Privado Kremer, Córdoba, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
  • Has either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
  • Has residual disability and active disease
  • Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)
  • Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP

Exclusion criteria

  • Meets the criteria for possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
  • Sensory CIDP (including sensory-predominant CIDP)
  • Polyneuropathy of other causes
  • Clinical diagnosis of systemic lupus erythematosus (SLE)
  • Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation

Treatment and study plan

Empasiprubart IV

Biological

Intravenous infusion of empasiprubart

Placebo IV

Other

Intravenous infusion of placebo

Primary outcomes

  1. Reduction of ≥1 point compared with baseline in aINCAT score at week 24

    Time frame: Up to 24 weeks

    The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

Secondary outcomes

  1. Change from baseline in I-RODS centile points score

    Time frame: Up to 24 weeks (part A) + 96 weeks (Part B)

    Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome).

  2. Change from baseline in MRC-SS at week 24

    Time frame: Up to 24 weeks

    The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome)

  3. Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24

    Time frame: Up to 24 weeks

  4. Time to reduction of ≥1 point from baseline in aINCAT score

    Time frame: Up to 24 weeks

    The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

  5. Change from baseline in TUG

    Time frame: Up to 24 weeks (part A) + 96 weeks (Part B)

    The Timed Up and Go Test (TUG) is a simple test top assess a person's mobility in which the time expended to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is measured.

  6. Time to increase of ≥1 point compared with baseline in aINCAT score up to week 24

    Time frame: Up to 24 weeks

    The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

  7. Change from baseline in grip strength (3-day moving average) of both hands over time

    Time frame: Up to 24 weeks (part A)

  8. Change from baseline in grip strength (daily average) for both hands

    Time frame: Up to 96 weeks (Part B)

  9. Change from baseline in MRC-SS over time

    Time frame: Up to 96 weeks (Part B)

    The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome).

  10. Change from baseline in aINCAT score over time

    Time frame: Up to 24 weeks + 96 weeks (Part B)

    The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

  11. Change from baseline in EQ-5D-5L over time

    Time frame: Up to 24 weeks (Part A) + 96 weeks (Part B)

    EQ-5D-5L questionnaire is a patient-reported outcome measure, ranging 0 to 100 (lower score, worse outcome).

  12. Change from baseline in RT-FSS over time

    Time frame: Up to 24 weeks (Part A) + 96 weeks (Part B)

    Rasch-Transformed Fatigue Severity Scale (RT-FSS) is a patient-reported outcome measure to distinguish fatigue from clinical depression.

  13. Change from baseline in BPI-SF over time

    Time frame: Up to 24 weeks (Part A) + 96 weeks (Part B)

    The Brief Pain Inventory-Short Form (BPI-SF) is a patientreported outcome measure to assess pain severity and pain interference.

  14. PGI-S values over time

    Time frame: Up to 24 weeks (Part A) + 96 weeks (Part B)

    The Patient Global Impression of Severity (PGI-S) is a patient-reported outcome measure that reflects the patient's belief about the severity of the illness.

  15. PGI-C values over time

    Time frame: Up to 24 weeks (Part A) + 96 weeks (Part B)

    The Patient Global Impression of Change (PGI-C) is a patient-reported outcome measure that reflects the patient's belief about the efficacy of treatment.

  16. Incidence of ADA against empasiprubart in serum

    Time frame: Up to 24 weeks + 96 weeks (Part B)

    Anti-drug antibodies

  17. Incidence of NAb against empasiprubart in serum

    Time frame: Up to 24 weeks + 96 weeks (Part B)

    Neutralizing antibodies

  18. Incidence of AEs and SAEs

    Time frame: Up to 24 weeks + 96 weeks (Part B)

  19. Percentage change from baseline in free C2 and total C2 over time

    Time frame: Up to 24 weeks (part A) + 96 weeks (Part B)

  20. Serum concentrations of empasiprubart over time

    Time frame: Up to 24 weeks (Part A) + 96 weeks (Part B)

  21. Reduction of ≥1 point in aINCAT over time

    Time frame: Up to 96 weeks (Part B)

    The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome)

  22. Increase of ≥1 point from baseline in aINCAT over time

    Time frame: Up to 96 weeks (Part B)

    The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Coppieters, MD

CONTACT

[email protected]

857-350-4834

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

Acronym: emnergize

Important dates

Study start
2025
Primary completion
2027
Study completion
2031
First posted
Jul 29, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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